Chronic fatigue (CF) and chronic fatigue syndrome (CFS) are disabling disorders that may be induced or aggravated by underlying sleep disturbances. The relationship between sleep quality and fatigue is still not fully elucidated. To evaluate the effect of improved sleep quality on fatigue, a randomized controlled and cross-over trial with nasal continuous positive airway pressure (nCPAP) is carried out in patients who present with a primary complaint of chronic disabling fatigue and who are found to have an apnea-hypopnea index (AHI) >= 15 on polysomnography (PSG).

The aim of this study is to address the issue of Continuous Positive Airway Pressure-responsiveness regarding fatigue as a presenting symptom in CF and CFS patient with obstructive sleep apnea (OSA), in the absence of underlying medical or psychiatric illness. The answer to this question may shed further light on the enigmatic relationship between sleep and fatigue. We also want to investigate the Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population. Zero-hypothesis: there is no effect.

At the end of the second treatment: effect evaluation. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.

Secondary Outcome Measures:

The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: baseline evaluation. [ Time Frame: At day 0 ] [ Designated as safety issue: No ]

The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: first treatment + effect evaluation. [ Time Frame: Treatment takes 28 days after first evaluation ] [ Designated as safety issue: No ]

The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: second treatment + effect evaluation. [ Time Frame: Treatment takes 28 days after second evaluation ] [ Designated as safety issue: No ]

Procedure: Active CPAP is compared with sham CPAP as a control intervention.

Patients are randomized into active or control arm. After the first treatment, a washout period is installed,after which therapy is switched according to the cross-over protocol. A CPAP device consists of a unit that generates airflow, which is directed to the airway via a mask. With active CPAP, the generated airflow creates a positive pressure and prevents upper airway collapse. With sham CPAP, the generated airflow creates a very low pressure.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients primarily referred for disabling, unexpected fatigue.

According to the Fukuda criteria, diagnostic work-up yields a final diagnosis of chronic fatigue (CF) or chronic fatigue syndrome (CFS).

Female patient of childbearing potential (premenopausal female biologically capable of becoming pregnant) has a confirmed negative pregnancy test at the start of the Continuous Positive Airway Pressure (CPAP) trial and has to employ an acceptable method of birth control.

Written, signed and dated informed consent must be obtained from each patient.

Patient able to understand and follow the requirements of the study and to comply.

Willing to abstain from taking any medication or treatment prohibited in the protocol.

Signs of nasal obstruction, including chronic use of topical nasal drugs.

Earlier CPAP treatment

Physical and mental disability that compromises the normal use of CPAP

CPAP intolerance

Current use of sedative (benzodiazepine and non-benzodiazepine GABA-esgic agonist) or antidepressant medication for a time period inferior to 3 weeks.

Female patient who is pregnant, lactating or has a positive pregnancy test result.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01368718